Validation of a French Version of the Confusion Assessment Method (CAM)

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT01775982

Collaborator

(none)

102

Enrollment

Locations

22.1

Duration (Months)

12.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To validate the French version of the CAM, a multicenter diagnostic study will be conducted. The principle of this study is identical to the study of Inouye which initially validated the CAM in 1990. This is to verify the diagnostic properties of the CAM (French version) compared to the gold standard represented by the confused state of psychiatric diagnosis using the DSM.

A representative sample of geriatric patients for whom a delirium is suspected, will be recruited in the various participating centers, patients will undergo two consecutive visits:

A visit by a geriatrician, during which the confused state of the patient will be evaluated using the French version of the CAM.
A visit by a psychiatrist during which the diagnosis of confusional state will be evaluated using the gold standard criteria of the DSM IV.

These two evaluations will be conducted on the same day and blinded from each other.

The order of these two procedures will be balanced within each center. This process will allow the calculation of diagnostic parameters of the CAM French version (validation competitive): sensitivity, specificity, positive and negative predictive values .

Condition or Disease	Intervention/Treatment	Phase
Confusion Delirium	Other: Psychiatric evaluation Other: Geriatric evaluation

Study Design

Study Type:

Observational

Actual Enrollment :

102 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Validation of a French Version of the Confusion Assessment Method (CAM): a Diagnostic Tool for Acute Confusion Among the Elderly

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Feb 2, 2016

Actual Study Completion Date :

Feb 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
Study population See inclusion and exclusion criteria. Intervention: Psychiatric evaluation Intervention: Geriatric evaluation A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.	Other: Psychiatric evaluation This evaluation is carried out in several stages: Assessment of cognitive functioning; Interview with a relative; Interview with caregivers; Evaluation of the presence of delirium according to DSM-IV criteria; Evaluation of the presence of anxiety, depressive syndrome, dementia or other DSM IV; Reports of adverse events. A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment. Other: Geriatric evaluation This evaluation includes a brief interview with a caregiver, diverse scorings (CAM, Delirium Index, Mini Geriatric Depression Scale, Modified Early Warning Score, Clinical Global Impression sclae, Algo Plus), and adverse event reporting. CAM scoring is carried out by a trained geriatrician and a trained nurse and/or a psychologist. A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.

Arm

Intervention/Treatment

Study population

See inclusion and exclusion criteria. Intervention: Psychiatric evaluation Intervention: Geriatric evaluation A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.

Other: Psychiatric evaluation

This evaluation is carried out in several stages: Assessment of cognitive functioning; Interview with a relative; Interview with caregivers; Evaluation of the presence of delirium according to DSM-IV criteria; Evaluation of the presence of anxiety, depressive syndrome, dementia or other DSM IV; Reports of adverse events. A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.

Other: Geriatric evaluation

This evaluation includes a brief interview with a caregiver, diverse scorings (CAM, Delirium Index, Mini Geriatric Depression Scale, Modified Early Warning Score, Clinical Global Impression sclae, Algo Plus), and adverse event reporting. CAM scoring is carried out by a trained geriatrician and a trained nurse and/or a psychologist. A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment.

Outcome Measures

Primary Outcome Measures

CAM French Version: diagnostic properties [Day 0]
Sensitivity, specificity, positive predictive value, negative predictive value

Secondary Outcome Measures

Reliability and quality of the french version of the CAM [Day 0]
Parameters of reliability and quality of the tool: Inter-rater Agreement (measured by a coefficient of correlation) between two evaluators: geriatrician and a nurse or psychologist Internal consistency of the questionnaire assessed by calculating Cronbach's alpha Time required for assessment Acceptability by clinicians Tolerance of patients
Feasibility of scoring with the French version of the Delirium Index [day 0]
Diagnostic properties of alternative algorithms constructed from items of CAM (French version) [day 0]

Other Outcome Measures

Patient age (years) [Baseline (day 0)]
Patient weight (kg) [Baseline (Day 0)]
Height (cm) [Baseline (day 0)]
Education level [baseline (day 0)]
primary, secondary, or higher
Living situation (qualitative) [baseline (day 0)]
Does the patient live at home? or is the patient institutionalized?
Presence/absence of a caregiver [baseline (day 0)]
Hospitalization within the past 3 months? yes/no [baseline (day 0)]
Has the patient fallen within the past year? yes/no [baseline (day 0)]
presence/absence of a visual or hearing impairment [baseline (day 0)]
patient position during evaluation [baseline (day 0)]
qualitative variable: in bed, in a wheelchair, sitting down
ADL (Activities of Daily Living) score for the 15 days preceding inclusion [baseline (day 0)]
IADL (Instrumental Activities of Daily Living) score for the 15 days preceding inclusion [baseline (day 0)]
ADL (Activities of Daily Living) score at the moment of inclusion [baseline (day 0)]
Clinical and para-clinical examination [baseline (day 0)]
Evaluation of the patient's physiological state [baseline (day 0)]
Diagnosis [baseline (day 0)]
Prescribed drugs [baseline (day 0)]
Comorbidities (Charlson score) [baseline (day 0)]
History of dementia, depression or another psychiatric disorder [baseline (day 0)]
Notification in the patient's history of dementia, depression or another psychiatric disorder, assessed by NPI-R and Mini GDS.
Severity of clinical condition [baseline (day 0)]
Severity of clinical condition: MEWS (Subbe CP et al, 2001) and CGI (Guy W 1976) + Charlson scale
Presence or absence of dementia before admission [baseline (day 0)]
Presence or absence of dementia before admission (IQCODE French version) (Jorm AF 1994 and Law S, 1995)

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A family member of the patient, or his/her "trusted person" must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
Hospitalization in geriatric short stay OR patient consulting at a geriatric assessment center / memory clinic OR geriatric day hospitalization
Patients for whom a state of confusion is suspected during the pre-inclusion visit run-in based on the following criteria:
Presence of a cognitive function disorder as defined by a score greater than or equal to 3 on the Short Portable Mental Status Questionnaire (SPMSQ) (Pfeiffer E, 1975) AND / OR
Presence of a mood disorder and / or behavior disorder (regardless of duration) according to the patient's family or caregivers
Presence of a caregiver who can answer questionnaires concerning activities of everyday life

Exclusion Criteria:

The patient is participating in another study
The patient is in an exclusion period determined by a previous study
The patient's family or "trusted-person" refuses to sign the consent
The patient does not understand french
Severe aphasia
Stay is < = 3 days

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH d'Alès	Alès	France	30103
2	CHU de Rouen - Hôpital de Bois-Guillaume	Bois Guillaume	France	76230
3	APHP - Hôpital Charles Foix	Ivry Sur Seine Cedex	France	94205
4	APHM - Hôpital Sainte-Marguerite	Marseille	France	13274
5	CHU de Montpellier - Centre Antonin Balmes	Montpellier cedex 5	France	34295
6	CHU de Nice - Hôpital de Cimiez	Nice	France	06003
7	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	France	30029
8	CHU de Reims - Hôpital Maison Blanche	Reims	France	51092